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A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) 1상 58

모집중
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임상시험 NCT07219550은(는) 기초과학을(를) 알아보기 위한 연구입니다. 이 연구는 건강한, 간 기능 장애에 대해 진행되며, 1상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 11월 5일에 시작되어 58명의 참여자를 모집하고 있습니다. 머크이(가) 진행하며, 2026년 8월 14일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 5일에 갱신되었습니다.
간단한 개요
The purpose of this study is to learn what happens to calderasib levels in a person's body over time. Researchers will measure what happens to calderasib levels in the body when it is given to participants with hepatic (liver) impairment and healthy participants. Researchers also want to learn about the safety of MK-1084 when it is given to people with hepatic impairment and if people with hepatic impairment can tole...더 보기
공식 제목

A Clinical Study to Evaluate the Effect of Hepatic Impairment on the Single-Dose Pharmacokinetics of MK-1084

질환명
건강한간 기능 장애
기타 연구 식별자
  • 1084-017
  • MK-1084-017 (기타 식별자) (MSD)
NCT 번호
실제 연구 시작일
2025-11-05
최신 업데이트 게시
2026-03-05
예상 연구 완료일
2026-08-14
계획된 등록 인원
58
연구종류
중재연구
단계/상
1상
상태
모집중
주요 목적
기초과학
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Calderasib
All participants will receive a single oral dose of calderasib on Day 1.
Calderasib
Oral Tablet
주요결과변수
결과변수측정값 설명시간 범위
Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib
Blood samples will be collected to determine the AUC0-last of calderasib in plasma.
At designated timepoints up to approximately 7 days post-dose
Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Calderasib
Blood samples will be collected to determine the AUC0-inf of calderasib in plasma.
At designated timepoints up to approximately 7 days post-dose
Area Under the Concentration Versus Time Curve from 0 to 24 hours post-dose (AUC0-24) of Calderasib
Blood samples will be collected to determine the AUC0-24 of calderasib in plasma.
Up to approximately 24 hours post-dose
Maximum Observed Drug Concentration (Cmax) of Calderasib
Blood samples will be collected to determine the Cmax of calderasib in plasma.
At designated timepoints up to approximately 7 days post-dose
Time to Maximum Observed Drug Concentration (Tmax) of Calderasib
Blood samples will be collected to determine the Tmax of calderasib in plasma.
At designated timepoints up to approximately 7 days post-dose
Apparent Terminal Half-life (t1/2) of Calderasib
Blood samples will be collected to determine the t1/2 of calderasib in plasma.
At designated timepoints up to approximately 7 days post-dose
Apparent Clearance (CL/F) of Calderasib
Blood samples will be collected to determine the CL/F of calderasib in plasma.
At designated timepoints up to approximately 7 days post-dose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib
Blood samples will be collected to determine the Vz/F of calderasib in plasma.
At designated timepoints up to approximately 7 days post-dose
이차결과변수
결과변수측정값 설명시간 범위
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants experiencing AEs will be reported.
Up to approximately 14 days
Number of Participants Who Discontinue Study Due to an AE
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The number of participants discontinuing the study due to AEs will be reported.
Up to approximately 14 days
참여 도우미
적격성 기준

연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용

All participants:

  • Has a body mass index (BMI) between 18.0 and 42.0 kg/m^2

Participants with hepatic impairment (HI):

  • Has a diagnosis of chronic, stable hepatic insufficiency at screening with features of cirrhosis

Healthy volunteers:

  • Is medically healthy with no clinically significant medical history

All participants:

  • Has a history of gastrointestinal disease which may affect food and drug absorption
  • Has a history of cancer (malignancy)
  • Has a positive result for human immunodeficiency virus (HIV)
  • Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing

Participants with HI:

  • Has had severe complications of liver disease within the preceding 3 months of screening
  • Has a history of recent (within 3 months prior to screening) variceal bleeds
  • Has evidence of hepatorenal syndrome
  • Is not in sufficient health, with regard to stability of HI, to undergo participation in the study with anticipated survival of < 3 months
  • Has a history of liver or other solid organ transplantation
  • Has an active infection requiring systemic therapy
  • Requires paracentesis more often than 2 times per month
  • Has transjugular intrahepatic portosystemic shunt and/or has undergone portacaval shunting
  • Has received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to dosing
  • Is using HIV protease inhibitors
  • Is positive for Hepatitis B surface antigen (HBsAg)
  • Is positive for HCV

Healthy volunteers:

  • Has positive results for HBsAg or HCV
Merck Sharp & Dohme LLC logo머크
연구 대표 연락처
연락처: Toll Free Number, 1-888-577-8839, [email protected]
3 1개국에 임상시험 장소

Arizona

Arizona Clinical Trials ( Site 0003), Chandler, Arizona, 85225, United States
Study Coordinator, 연락처, 210-253-3426
모집중

Florida

Orlando Clinical Research Center ( Site 0001), Orlando, Florida, 32809, United States
Study Coordinator, 연락처, 407-240-7878
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Texas

The Texas Liver Institute ( Site 0002), San Antonio, Texas, 78215, United States
Study Coordinator, 연락처, 480-470-4000
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